Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Osteoarthritis of Hip Clinical Trial

Official title:

Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01668160
• Other study ID #: 2012P000925
• Secondary ID: 216494
• Status: Withdrawn
• Phase: N/A
• First received: August 10, 2012
• Last updated: November 4, 2013
• Start date: February 2012
• Est. completion date: January 2020

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female.

2. 25 to 75 years of age.

3. Subjects requiring revision total hip replacement.

4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria:

1. Subjects with limited life span.

2. Subjects with difficulty in comprehending study protocol for any reason.

3. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.

4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

• A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure of Primary THA
• Osteoarthritis of Hip
• Osteoarthritis, Hip

Intervention

Procedure:
• Bead placement during revision hip replacement surgery
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment/questionaire HOOS	Hip disability and Osteoarthritis Outcome Score	Pre-op, 1, 2, 3, 5 years after surgery	No
Other	Assessment/Questionaires Harris Hip Score	Hip specific questionaire	Pre-op, 1, 2, 3, 5 years after surgery	No
Other	Assessment/Questionaire UCLA Activity Score	Measure of activity level	Pre-op, 1, 2, 3, 5 years after surgery	No
Other	Assessment/Questionaire EQ-5D	General health and cost effectiveness measure	Pre-op, 1, 2, 3, 5 years after surgery	No
Other	Assessment/Questionaire Case Mix indicator	Determines comorbidities	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Primary	Stability of Acetabular and femoral components	RSA films will be taken at the prescribed time intervals to measure component mothion over time.	1, 2, 3, 5 years after surgery	No
Secondary	Wear of the polyethlene component	The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.	1, 2, 3, 5 years after surgery	No